Intuitive Surgical, Inc.: Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

Recall number

Z-2782-2015

Recalling firm

Intuitive Surgical, Inc.

Product

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

Status

Terminated

Initiated

2015-09-09

Posted

2015-09-17

Terminated

2015-11-02

Reason

B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.

Root cause

Package design/selection

Action

Intuitive sent an Urgent Medical Device Correction letters dated September 9, 2015 to all customers via traceable method. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to : 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, anesthesiologist and members of your medical staff who perform da Vinci Surgery procedures. 2. Prior to use, open and inspect current supply of Fluorescence Imaging Procedure Kits. If kits include B. Braun stopcocks, discard stopcocks and replace with other stopcocks 3. Continue to perform procedures using other stopcocks 4. Continue to follow directions provided in Florescence Imaging Procedure Kit IFU (p/n 550976), If a sterile item in a Fluorescence Imaging Procedure Kit becomes compromised in any way, do not use the compromised item; replace it with a new item. 5. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 6. Please retain a copy of this notice near your Fluorescence Imaging Procedure Kit inventory. Questions or concerns should be directed to Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: " (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupportservicesupport@intusurg.com

Quantity

1200 kits

Distribution

US Nationwide Distribution

Lot, serial or model codes

Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301.  Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902.  Product number 950156-03: Lot numbers : NQ144001 NQ150501  NQ143902 NQ150601  NQ143901 NQ150602  NQ143803 NQ150703  NQ143601 NQ150701  NQ143602 NQ150702  NQ144502 NQ150801  NQ144801 NQ150901  NQ145202 NQ150802  NQ144901 NQ151001  NQ145301 NQ151002  NQ145201 NQ151101  NQ150301 NQ150501  NQ144001.

510(k) numbers

["K141077"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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